Natural History of MTBI-related Convergence Insufficiency & Effectiveness of Vision Therapy for MTBI-related CI

NCT ID: NCT06848673

Last Updated: 2025-02-27

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-11-01
• Study Completion Date: 2028-09-30

Brief Summary

The design of this project is a pilot study, a type of feasibility study conducted in preparation for subsequent RCTs that will assess the effectiveness of office-based vergence/accommodative therapy with movement (OBVAM) for mTBI-related convergence insufficiency.

Detailed Description

The design of this project is a pilot study, a type of feasibility study conducted in preparation for subsequent RCTs that will assess the effectiveness of interventions or therapies. In this application, we refer to this pilot and feasibility study as a pilot clinical trial (PCT). This feasibility PCT aims to identify potential challenges, logistical issues, and unforeseen complications. To do this, we will examine various feasibility aspects, including recruitment and retention, randomization, intervention protocols, outcome measures, ethical considerations, safety monitoring, resource availability, and stakeholder feedback. By conducting this PCT, we can test our procedures and gather preliminary data. The primary objectives of this feasibility PCT are to 1) Determine the feasibility of conducting future full-scale RCTs by evaluating the effectiveness of a novel vergence/accommodative/move (OBVAM) therapy program for young adults with mTBI-CI and 2) Better understand the progression and stability (i.e., natural history) of mTBI-CI over the 6 weeks following enrollment.

Conditions

Convergence Insufficiency

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Immediate Office-Based Vergence/Accommodative Therapy with Movement (OBVAM)

16 sessions, twice per week of office-based vergence/accommodation therapy (OBVASM)While OBVAM therapy retains the essential elements of OBVAT. The OBVAM therapy protocol has four phases. Phase 1 targets visual/vestibular issues typical in mTBI-CI by integrating version eye movements, such as saccades and pursuits, with head and body movements. It also includes gross convergence, monocular accommodative (focusing) flexibility, and simple convergence procedures. The subsequent phases concentrate on enhancing ramp vergence amplitudes and improving accommodative facility (Phase 2), focusing on vergence facility and endurance (Phase 3), and integrating vergence and accommodation (Phase 4). Head and body movements are incorporated into some therapy procedures in Phases 3 and 4.

Group Type: EXPERIMENTAL

Office-Based Vergence/Accommodative Therapy with Movement (OBVAM)

Intervention Type: OTHER

Head and body movements are incorporated into some therapy procedures in Phases 3 and 4. Additional details are provided in the Overall Program Narrative. Participants undergoing office-based VAM therapy will be prescribed home therapy procedures including the HTS2 Home Vision Therapy System (https://htsvision.com/) thrice weekly to support their in-office VAM therapy. This software progressively increases fusional convergence and divergence demands, offers instant user feedback, and will allow us to track participants' usage and progress. Basic procedures like free-space fusion cards and Brock String will also be prescribed for home therapy.

Delayed Office-Based Vergence/Accommodative Therapy with Movement (OBVAM)

Same as immediate group but delayed 6 weeks

Group Type: ACTIVE_COMPARATOR

Office-Based Vergence/Accommodative Therapy with Movement (OBVAM)

Intervention Type: OTHER

Head and body movements are incorporated into some therapy procedures in Phases 3 and 4. Additional details are provided in the Overall Program Narrative. Participants undergoing office-based VAM therapy will be prescribed home therapy procedures including the HTS2 Home Vision Therapy System (https://htsvision.com/) thrice weekly to support their in-office VAM therapy. This software progressively increases fusional convergence and divergence demands, offers instant user feedback, and will allow us to track participants' usage and progress. Basic procedures like free-space fusion cards and Brock String will also be prescribed for home therapy.

Interventions

Office-Based Vergence/Accommodative Therapy with Movement (OBVAM)

Head and body movements are incorporated into some therapy procedures in Phases 3 and 4. Additional details are provided in the Overall Program Narrative. Participants undergoing office-based VAM therapy will be prescribed home therapy procedures including the HTS2 Home Vision Therapy System (https://htsvision.com/) thrice weekly to support their in-office VAM therapy. This software progressively increases fusional convergence and divergence demands, offers instant user feedback, and will allow us to track participants' usage and progress. Basic procedures like free-space fusion cards and Brock String will also be prescribed for home therapy.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• • Age 18 to 35 years inclusive

• Medical diagnosis of mTBI or concussion > 1 month ago and no longer than 6 months ago
• Convergence Insufficiency Symptom (CISS score) ≥ 21
• Best-corrected VA of 20/25 or better in both eyes at distance & near
• Willingness to wear refractive correction, if indicated
• Random dot stereopsis of 500 arcsec or better (Randot Stereo Test)
• Receded NPC of ≥6 cm
• Insufficient PFV (< 15∆ or PFV blur point less than twice the near exophoria magnitude)
• Wearing refractive correction for cycloplegic refractive errors of:
• ≥ +1.25 D SE hyperopia or ≥ -1.00 D SE myopia in either eye
• ≥ 1.25 D astigmatism in either eye, ≥ 1.00 D SE anisometropia
• Astigmatism axis within ±10 degrees if magnitude is ≤1.00 D and within ±5 degrees if >1.00 D

Exclusion Criteria

• • No previous treatment for CI

• No previous diagnosis of CI from an ophthalmologist or optometrist
• No medications known to affect accommodation or vergence
• Investigator & patient willing to forgo all other CI treatment other than that assigned by randomization

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Salus University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mitchell Scheiman, OD, PhD

Role: PRINCIPAL_INVESTIGATOR

Drexel University

Central Contacts

MItchell Scheiman, OD, PhD

Role: CONTACT

ms5758@drexel.edu

215-780-1427

Susan Cotter, OD, MS

Role: CONTACT

scotter@ketchum.edu

215-780-1427

Other Identifiers

VR230111

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

VR230111

Identifier Type: -

Identifier Source: org_study_id